On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined that these additives do not pose a risk to public health under the conditions of their intended use. The agency acknowledges that these flavorings and adjuvants are used in very small amounts and their use results in very low levels of exposures and low risk. Nonetheless, in light of the animal data showing carcinogenicity, the agency concluded it had to withdraw their authorization as food additives as a matter of law under the Delaney clause. FDA intends to enforce the Rule’s requirements only on products manufactured after October 9, 2020, containing one or more of the six synthetic flavoring substances.
Proposition 65
OEHHA Proposes Significant Amendment on Determining the Daily Intake of Listed Chemicals as Causing Reproductive Toxicity
By Martin Hahn & Xin Tao on
Posted in Food Labeling, Proposition 65
Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average concentration of a listed chemical as causing reproductive toxicity (e.g., lead) be based on products from the same manufacturing facility; and (2) the dietary exposure to a listed chemical as causing reproductive toxicity be calculated using the arithmetic mean. If adopted, the proposed changes would overrule the court decision in Environmental Law Foundation v Beechnut Nutrition Corp on how to determine the daily intake of listed chemicals as causing reproductive toxicity. The change could impose additional testing requirements on the industry and could create a more rigid standard for falling within a safe harbor. We encourage food companies to evaluate whether the proposed changes would adversely impact their current Proposition 65 compliance positions.
Comments to the proposed regulation are due by November 19, 2018. In addition, a public hearing on the proposed amendment would be scheduled on request. To request a hearing, OEHHA needs to be notified no later than November 5, 2018.
California Appeals Court Reverses Decision Requiring Proposition 65 Warnings on Cereals for Acrylamide
By Martin Hahn, Xin Tao & Erika Ward on
Posted in FDA, Proposition 65
A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning for acrylamide on these cereals would pose an obstacle to the federal scheme, and therefore is preempted by federal law. To support the ruling, the panel of appeals court judges referenced the advisory letters issued by the FDA to the California regulators and Attorney General with “persuasive reasoning why Proposition 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.” We do not know if the decision will be appealed to the California Supreme Court.
Proposed OEHHA Regulation Declares No Significant Risk of Listed Proposition 65 Chemicals in Coffee
By Martin Hahn, Xin Tao & Erika Ward on
Posted in OEHHA, Proposition 65
On Friday, June 15th, the California Office of Environmental Health Hazard Assessment (OEHHA) announced a proposed regulation clarifying that exposures to Proposition 65 chemicals in coffee do not pose a significant cancer risk. The proposal follows a recent California Superior Court ruling that the coffee industry failed to meet its burden of proof on its alternative significant risk level (ASRL) affirmative defense to its failure to warn of the presence of acrylamide in coffee under Proposition 65. The proposed regulation is significant as, if adopted, it would effectively exempt coffee products from Proposition 65 carcinogen warning requirements.
California Judge Rules Against the Coffee Industry in Notable Acrylamide Proposition 65 Case
By Martin Hahn & Xin Tao on
Posted in Food Labeling, Proposition 65
Food companies and retailers doing business in California should take note of the recent proposed statement of decision in the case challenging the coffee industry’s failure to warn of the presence of acrylamide in coffee under Proposition 65. On March 28, 2018, the Superior Court of California at Los Angeles County issued a proposed statement of decision ruling the coffee industry failed to meet their burden of proof on their alternative significant risk level (ASRL) affirmative defense. To the extent the ruling is not overturned on appeal, it would set the precedent for applying the ASRL for other listed substances that form during the cooking of food.
Acrylamide is not intentionally added to coffee. Instead, when coffee beans are roasted, a chemical reaction (the Maillard reaction) occurs causing the asparagine and sugars in coffee beans to form the chemical. FDA reports “acrylamide is found mainly in foods made from plants, such as potato products, grain products, or coffee” and that generally it is “more likely to accumulate when cooking is done for longer periods or at higher temperatures.” In the past few years, bounty hunters have filed multiple actions against companies marketing foods in California that contain acrylamide and do not bear the Proposition 65 warning. In light of the recent ruling, it would be prudent for companies that manufacture or market food products that contain acrylamide to reexamine their obligations under Proposition 65.
Sunset of the Proposition 65 Interim BPA Warning Regulation
By Martin Hahn & Xin Tao on
The Proposition 65 Interim BPA warning regulation that allows companies to rely on a generic warning posted in California retail establishments will sunset on December 30, 2017. Food and beverage companies that have BPA containing packages in California and that have been relying on the interim BPA warning regulation for compliance should reassess their Proposition 65 warning obligations prior to December 31, 2017.
By way of brief background, effective May 11, 2016, OEHHA started requiring warnings for consumer products containing BPA under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65 or Prop 65). Due to the high percentage of the canned and bottled food and beverages that were packaged with BPA-containing materials in California at that time, OEHHA adopted an emergency regulation that allowed the temporary use of a standard point-of-sale warning message (e.g., posting of warnings at checkout stands in retail stores) for BPA. In July 2016, OEHHA proposed an interim rule that essentially extended the temporary regulation through December 30, 2017. The interim regulation also required food companies that exercised this option to provide OEHHA with a list of all food products in which BPA was intentionally used in the manufacture of the can lining or jar or bottle seals.
As of today, there are a total of over 23,000 entries of canned or bottled food products listed in the publicly-accessible OEHHA database for products packaged with BPA-containing materials. The sheer number of listed products in the database suggests that many food and beverage companies have been relying on the interim BPA warning regulation for compliance. On December 31, 2017, those food and beverage companies with products listed in the OEHHA database that have not phased out the use of BPA in their packaging should assess their options for compliance with Proposition 65. Companies should consult with legal counsel when assessing whether they will have an obligation to provide a Prop 65 warning and if so, the type of warning that should be required.
California’s Proposition 65 Warning Requirements for Furfuryl Alcohol Will Become Effective Soon
By Martin Hahn & Xin Tao on
Posted in OEHHA, Proposition 65
Effective September 30, 2017, California’s Office of Environmental Health Hazard Analysis (OEHHA) will require warnings for consumer products containing furfuryl alcohol under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Proposition 65). Furfuryl alcohol is a food contaminant that can occur in a potentially significant number of thermally processed foods because it forms as a result of the Maillard reaction that gives many foods a characteristic brown color. As has been the case with other food contaminants listed under the Proposition 65, we expect private litigants to file lawsuits after the warning requirement becomes effective. Companies marketing or manufacturing food products that undergo a Maillard reaction should consider whether furfuryl alcohol is forming and should evaluate their potential obligations and exposure in anticipation of the September 30 effective date.
New Wave of California Proposition 65 Acrylamide 60-Day Notices
By Martin Hahn, Brian Eyink, Xin Tao & Kaitlin Welborn on
Posted in GRAS, Proposition 65
Food companies should be aware of a recent, new wave of Proposition 65 (Prop 65) challenges targeting acrylamide in food. In the past year, private litigants—particularly the Center for Environmental Health (CEH)—have filed numerous 60-day notices indicating their intent to sue food companies that allegedly fail to warn consumers of harmful levels of acrylamide under the “bounty hunter” provisions of California’s Proposition 65 (Prop 65). These 60-day notices target snack products made from potatoes as well as prune juice, black olives, tofu scramble, and cookies. Below, we provide a refresher of the acrylamide Prop 65 litigation as well as a summary of these recent 60-day notices. A food company doing business in California is well advised to proactively self-assess its exposure to potential Prop 65 liabilities.
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California’s OEHHA Adopts New Proposition 65 “Clear and Reasonable Warnings” Regulations
By Martin Hahn & Xin Tao on
Effective on August 30, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) will adopt new regulations regarding the manner in which clear and reasonable warnings should be given under the Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986). By way of brief background, Proposition 65 requires businesses to provide “clear and reasonable warnings” when they knowingly and intentionally cause an exposure to a listed chemical to any individual in California. Under the current Article 6 to Title 27 of the California Code of Regulations, the “clear and reasonable warnings” must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure.
OEHHA finds the current regulations lack the specificity necessary to ensure the public receives useful information about potential exposures. OEHHA intends to provide more useful information to California consumers through the new regulations. One of the many notable changes is the requirement that the warning needs to contain the name of one or more of the listed chemicals in the consumer products. OEHHA also tries to clarify the relative responsibilities of different parties in the supply chain to provide consumer product exposure warnings. Businesses have the option of continuing to comply with the current version of the regulations until August 30, 2018, or comply with these new regulations in advance of the effective date.
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California’s OEHHA Proposes Additional Revisions to Prop 65 “Clear and Reasonable Warnings” Regulation
By Martin Hahn & Xin Tao on
Posted in Proposition 65
We previously reported that on March 25, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a revised proposed regulation to amend the requirements for “clear and reasonable warnings” under the Proposition 65. On May 18, 2016, OEHHA published a slightly revised version of the proposed regulation. This most recent version includes additional changes to the March 25 proposed regulation based on the additional comments the agency received. While most of these revisions made by OEHHA are non-substantive, we encourage food and beverage manufacturers, distributors, retailers, and restaurants to closely examine the proposal and assess how the new regulation will affect their compliance with the Prop 65 warning requirements. Comments specifically addressing the changes made by OEHHA are due on June 6, 2016.
We provide a brief overview of the new proposal and highlights a few changes subject to public comments.
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